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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number NS-9008
Device Problem Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Date 10/25/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Upon completion of the investigation, a follow up report will be filed.
 
Event Description
The device was implanted via l-p shunt to the patient on (b)(6) 2014. The initial pressure settings are unknown. It was found that the devices have turned over after mri scanning on (b)(6) 2016. The surgeon tried to change setting many times but the device couldn¿t work properly. The surgeon replace with another one. There were no adverse consequences associated with this event and no further information was provided by hospital.
 
Manufacturer Narrative
Device evaluation: date received by mfr, type of reports, if follow-up, what type?, device evaluated by mfr?, evaluation codes, additional mfr narrative. Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve and are attached. The position of the cam when valve was received was 100 mm h2o. The valve was hydrated for 24 hours. The valve was visually inspected: marks on the underside of the needle base were noted. The valve was tested for programming with programmer 82-3126 with serial number (b)(4), the valve passed the test. The valve was flushed, the valve passed the test no occlusion was noted. The valve was leak tested, no leaks were noted. The catheters were irrigated, no occlusions noted. The valve was reflux tested. The valve passed the test. The siphon guard was tested. The valve passed the test. The valve was dried. The siphon guard was removed. The valve was then pressure tested, the valve passed the test. Review of the history device records confirmed the valve product code ns9008 with lot crbcbw, conformed to the specifications when released to stock in 7th march 2014. No root cause could be determined, as the problem reported by the customer could not be duplicated the valve programmed. As noted in the ifu programming procedure in case of an inverted valve. The root cause for the marks on the underside of the needle base are probably caused by a needle. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
 
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Brand NameHAKIM VALVE
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29
ch-2400 le locle
SZ
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6116785
MDR Text Key60548643
Report Number1226348-2016-10791
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2018
Device Catalogue NumberNS-9008
Device Lot NumberCRBCBW
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/21/2016 Patient Sequence Number: 1
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